COLDTAC SEVERE COLD MAX RELIEF- acetaminohpen, dextromethorphan hydrobromide capsule, liquid filled

Coldtac Severe Cold by

Drug Labeling and Warnings

Coldtac Severe Cold by is a Otc medication manufactured, distributed, or labeled by OPMX LLC, Rebase Lifescience Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each Softgel)

Acetaminophen 325mg

Dextromethorphan HBr 10mg

Purpose

• Pain reliever/Fever reducer
• Cough suppressant

Uses

Temporarily relieves common cold/flu symptoms:

• Cough due to minor throat & bronchial irritation
• Sore throat
• Headache
• Minor aches and pains
• Fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

• More than 4 doses in 24 hrs, which is the maximum daily amount for this product.
• With other drugs containing acetaminophen.
• 3 or more alcoholic drinks daily while using this product.

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

• Skin redding
• Blisters
• Rash
• If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

• With any other drug containing acetaminophen (prescription or nonprescription).
• If you are not sure whether a drug contains acetaminophen, ask a doctor or a pharmacist.
• If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson´s desease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• Liver disease
• Heart disease
• Diabetes
• High blood pressure
• Trouble urinating due to enlarged prostate gland
• Cough that occurs with too much phlegm (mucus)
• Persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis or emphysema.

Ask a doctor or pharmacist before use if you are:

Taking the blood thinning drug warfarin.

When using this product,

do not use more than directed.

Stop use and ask a doctor if

• You get nervous, dizzy or sleepless.
• Symptoms get worse or last more than 5 days (children) or 7 days (adults).
• Fever gets worse or lasts more than 3 days.
• Redness or swelling is present.
• New symptoms occur.
• Cough comes back, or occurs with rash or headache that lasts.

These could be signs of a serious condition.

Keep out of reach of children.

Keep out of reach of children.

If pregnant or breast-feeding,

ask a health professional before use.

Overdose warning:

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• Take only as directed.
• Do not exceed 4 doses per 24 hours.

• Adults & children 12 yrs & over: 2 softgels with water every 4 hrs
• Children 4 to under 12 yrs: Ask a doctor
• Children under 4 yrs: Do not use

Other information

• Store at room temperature.

Inactive ingredients:

FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol, titanium dioxide.

Questions?

Call toll free 619-600-5632

Monday through Friday 9AM - 5PM EST

Distributed By

Made for:

RRX

San Diego, CA 92154

Exlusivley distributeed by:
OPMX
Chula Vista, CA 91910

Phone: 619-600-5632

PRINCIPAL DISPLAY PANEL

NDC: 69729-808-10

COLDTAC

SEVERE COLD

Acetaminophen 325mg / Dextromethorphan HBr 10mg

MAX RELIEF

Cold and Flu Relief:

Para el alivio de las molestias de la Gripe:

Headache & Sore Throat

Dolor de Cabeza y Garganta

Fever Reducer

Reduce la Fiebre

Cough Suppressant

Supresor de la Tos

10 Soft Gels

INGREDIENTS AND APPEARANCE

COLDTAC SEVERE COLD  MAX RELIEF
acetaminohpen, dextromethorphan hydrobromide capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69729-808
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GELATIN (UNII: 2G86QN327L)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	AP01
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69729-808-10	1 in 1 CARTON	01/29/2026
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	01/29/2026

Labeler - OPMX LLC (029918743)

Establishment
Name	Address	ID/FEI	Business Operations
Rebase Lifescience Private Limited		861502593	manufacture(69729-808)